More Me-Too Products, Not Fewer 
Posted by Carlos on Sep 26, 2012

An article by our good friend Derek Hennecke in the September issue of Drug Development & Delivery really struck a nerve with us…but in a good way.

To quote (with our emphasis):

An essay in the Journal of the American Medical Association published in February of last year argued that drugs seeking FDA approval should demonstrate not just non-inferiority, but superiority compared to available drugs. The article lambasted the FDA for approving pitavastatin (Livalo), resulting in eight statins approved for use in the US. The author contends that eight is too many, and that new drugs should be at least safer, more efficient, or suitable for other populations, such as the elderly or children.

Such a move would hamper innovation further. No drug company ever sets out to develop a me-too drug. They always start with a molecule they believe is better. When it turns out the drug’s efficacy is similar to an existing drug, does that really mean this new molecule should be thrown out with the bathwater? There are so many reasons to let these drugs come to market. Doctors, for one, are always on the lookout for precisely the kind of options these drugs present. When a patient doesn’t respond to one drug, or perhaps reacts with a nasty side effect, doctors need options to be able to match the patient to the drug that performs best for him or her. Perhaps even more importantly, shutting down promising new molecules closes an entire avenue of potential innovation. The availability of any one new molecule could lead to untold transformational discoveries that would never otherwise see the light of day.

Derek is absolutely correct on this one.
To think of it another way…how can a physician practice “personalized medicine” when s/he only has one or two choices for each mechanism of action?
Will the eighth statin have a tremendous commercial future, remembering that Lipitor

English: ball and spoke model image of the dru...

More, please…

was fifth to market?

Maybe. Maybe not.
Commercial success is in the eyes of the company, not Wall Street. So while the pundits bemoan the loss of revenues from Lipitor, a smaller company with a different option and with Peak Year Sales in the low millions might be quite content with their “me too” product.
So we agree with Derek. We need more options within each mechanism of action, not fewer. If something comes along that is dramatically clinically superior, then the practice of medicine will shift accordingly.
But, to insist that one or two products within a given mechanism of action is a view that’s far too narrow, and constrains the personalization of medicine to an unrealistic degree.
Google Plus   Facebook   Twitter
Powered By : Supra International Inc.